AccessGUDID - DEVICE: PK7400 TP HA REAGENT (05060515140030)

GUDID

Device Identifier (DI) Information

Brand Name: PK7400 TP HA REAGENT
Version or Model: B11186
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEWMARKET BIOMEDICAL LIMITED

Primary DI Number: 05060515140030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217095816 *Terms of Use

Device Description: PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61225	Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYR	Test, Donor, Syphilis, Antigens, Treponemal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3600 tests

Device Record Status

Public Device Record Key: ed69718e-11ba-4105-8057-62114e29da4b
Public Version Date: November 22, 2019
Public Version Number: 1
DI Record Publish Date: November 14, 2019